Mupfumi 2014.
| Study characteristics | ||
| Methods | Single centre, pragmatic individually‐randomized controlled trial | |
| Participants | Participants included were consecutive symptomatic and asymptomatic HIV‐infected participants initiating anti‐retroviral therapy 18 years old and older Female: 55% HIV infection: 100% (HIV clinic) Setting: specialized infectious disease hospital Country: Zimbabwe Sample size: 424 |
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| Interventions | participants provided 2 spot sputum specimens at least 1 hour apart. If participants were unable to expectorate sputum, attempts were made to induce sputum using nebulized 6% hypertonic saline. Samples in the microscopy group had a direct smear completed on each sample followed by staining with auramine O (Leica, Germany). Xpert MTB/RIF assays were completed on direct sputum. |
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| Outcomes | Primary outcome: proportion of participants who were diagnosed with ART‐associated tuberculosis, or who died within 3 months of randomization | |
| Notes | Target condition: Tuberculosis Case definition: participants with at least 1 positive Xpert or microscopy (for 'scanty' samples, both smears needed to be recorded as 'scanty') |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation list was generated by the data manager and supplied to the laboratory manager in sealed envelope |
| Allocation concealment (selection bias) | Low risk | Allocation was given in sealed opaque envelope |
| Baseline characteristics similar (selection bias) | Low risk | Similar baseline characteristics in both groups |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not done. Blinding was not feasible given a pragmatic trial design, however, sample transporter to the central laboratory for quality control was blinded to participant identification |
| Protection against contamination (performance bias) | Low risk | Randomization was generated by a data manager, and codes were kept in envelopes; participants were assigned based on codes. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding was not feasible; death occurring after tuberculosis diagnosis was considered tuberculosis‐related death, however, the authors did not clearly explain the different ways to verify death. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The proportion of loss to follow‐up was not significantly different between groups |
| Selective reporting (reporting bias) | Low risk | All outcomes in the methods were reported |
| Other bias | Low risk | Not detected |